Osteoarthritis (OA) is a chronic and debilitating disease which occurs when the protective cartilage in the joints deteriorates and breaks down. It can affect any joint in your body, but it most commonly occurs in the joints in your hands, knees, hips, and spine. Its symptoms include stiffness, pain, and swelling of the joint. Approximately 70 million Europeans are affected by the condition, and 25% of these individuals cannot perform the major activities of daily living. Treatment options include pain management with non-steroidal anti-inflammatories, corticosteroid injections, and joint replacement but there is currently no cure for OA.
ADIPOA-2 contributed to the development and validation of a revolutionary new stem cell treatment for OA. This therapy uses the patient's own stem cells. These cells are extracted from the patient's adipose (fatty) tissue and cultured under rigorous quality control in cell manufacturing facilities, before being injected into the patient's knee joint, where the stem cells help to reduce inflammation, and promote the repair of damaged cartilage. This treatment has already shown promise in an earlier clinical trial. Now ADIPOA2 is carrying out new research and conducting a larger clinical trial, which will move this treatment closer to the market and offer hope to the millions of Europeans who suffer from pain and debility as a result of OA. ADIPOA2 will also make an important contribution to the development of Europe's stem cell manufacturing infrastructure. This is vital if stem cell therapies are to become part of the therapeutic mainstream. ADIPOA2's research is making significant contributions in the following areas:
Developing cell production infrastructure:
The challenge of upscaling the production of high-quality stem cell products is one of the most significant barriers to the mainstream use of cellular therapies. ADIPOA2 is directly addressing this challenge by producing consistent batches of high-quality autologous (patient derived) stem cells under GMP (good manufacturing practice)- compliant conditions. The cells used in the ADIPOA2 trial were produced in centres in France, Germany and Ireland. This ground-breaking multi-site approach required cooperation between manufacturing centres, helping to develop the production infrastructure that will allow for the wider use of stem cell therapies. ADIPOA2 also contributed to European regulatory experience with stem cell products.
Mechanism of Action:
The ways in which stem cells control inflammation and promote tissue repair are still not fully understood. ADIPOA2 conducting extensive research into the mechanism of action of these cells, helping to explain how they treat osteoarthritis, and how they may function in the treatment of other conditions. This knowledge is crucial to develop new assays and potency tests which will provide a affordable means to evaluate the clinical efficacy of stem cell treatments.
Clinical trial:
Building on the success of the earlier ADIPOA trial, ADIPOA2 initiated a Phase II randomised clinical trial of patient-derived stems cells in the treatment of advanced OA of the knee. This trial will involve the treatment of 150 patients across ten hospitals, located in France, Germany, Ireland, Italy, the Netherlands, and the United Kingdom. The trial assessed the safety and efficacy of the stem cell treatment, and will provide data for the validation and development of this treatment. Although it did not prove possible to complete the trial within the timespan of ADIPOA2, the initial results allowed partners to secure the funding required to continue the trial beyond the lifetime of the project.
